Single dose open-label PK/PD, safety and tolerability of dabigatran etexilate mesilate given at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years and 1 year to less than 2 years.
Phase 2
Withdrawn
- Conditions
- bloodclotdeep venous thromboembolism10014523
- Registration Number
- NL-OMON37049
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 3
Inclusion Criteria
Stable pediatric patients objectively diagnosed with a venous thrombotic event
Exclusion Criteria
- weight less than 9 kg;
- previous history of cerebral venous thromboembolism;
- conditions associated with a increased risk of bleeding;
- severe renal dysfunction;
- active infective endocarditis;
- hepatic disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- incidence of all bleeding events (major and minor);<br /><br>- incidence of all adverse events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- changes in laboratory and clinical parameters such as liver enzymes, ECG and<br /><br>physical examination;<br /><br>- occurrences of clinical outcomes including recurrent thrombosis, post<br /><br>thrombotic syndrome (PTS), pulmonary emboli (PE), and total and venous<br /><br>thrombolic event (VTE) related mortality objectively assessed for example by<br /><br>ultrasound, venography or CT scan;<br /><br>- global assessment of tolerability to studymedication.</p><br>